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NCT01093183 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide and Cyclophosphamide in Treating Patients With Previously Treated Hormone-Refractory Prostate Cancer
A Phase 1 study, sponsored by University of Nebraska.
- Terminated
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT01093183: Clinical Trial Phase 1 study, sponsored by University of Nebraska.
NCT01093183 is a Phase 1 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01093183, a Phase 1 study, was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with cyclophosphamide and to see how well they work in treating patients with previously treated hormone-refractory prostate cancer. Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lenalidomide together with cyclophosphamide may kill more tumor cells.
Primary Outcome
Defined to be the dose cohort below which 2 of 3 or 3 of 6 patients experience dose-limiting toxicities in course 1 or the highest dose cohort of 25 mg.
Interventions
- OTHER laboratory biomarker analysis
- OTHER questionnaire administration
- DRUG cyclophosphamide
- OTHER quality-of-life assessment
- DRUG lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-03-04 |
| Est. Completion | 2015-05-19 |
| Phase | Phase 1 |
Why NCT01093183 stopped before completion
NCT01093183 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01093183 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01093183 about?
NCT01093183 is a clinical study titled "Lenalidomide and Cyclophosphamide in Treating Patients With Previously Treated Hormone-Refractory Prostate Cancer". This phase I/II trial studies the side effects and best dose of lenalidomide when given together with cyclophosphamide and to see how well they work in treating patients with previously treated hormone-refractory prostate cancer. Lenalidomide may stop the growth of prostate cancer by blocking blood ...
What is the current status of trial NCT01093183?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2010-03-04. Estimated completion is 2015-05-19.
What interventions are being tested in trial NCT01093183?
The interventions under investigation include: laboratory biomarker analysis (OTHER), questionnaire administration (OTHER), cyclophosphamide (DRUG), quality-of-life assessment (OTHER), lenalidomide (DRUG).
Who is sponsoring clinical trial NCT01093183?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01093183's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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